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But HEMO has competition on the GBM brain cancer front; the following has been reported most recently:
Australian of the Year Award Winners 2024 - Prof. Richard Scolyer (he himself, his own GBM patient) and Prof. Georgina Long of the Melanoma Institute of Australia.
https://www.bbc.co.uk/news/world-australia-67870595
https://melanoma.org.au/news/melanoma-science-race-against-brain-cancer-national-press-club/
Encouraging developments that help support the potential of HEMO's science - but HEMO needs to be moving along, with new funding.
Slide 15:
Summary
• A novel proprietary technology.
• Proof of Concept has been established
• Directly applicable to the US Department of Defense and HHS objectives.
• Technology is ready for translational science to develop and test products.
• BAIT Biotechnology has the facility and people to execute a program
Slide 14:
Current Product Candidates
{remember these relate only to the plan for BAIT Biotechnology)
CBR
• Ebola, Marburg (Filoviridae family) – POC in vitro using synthetic non-replicating virus.
• SARS-CoV-2 (Coronaviridae family) – POC in vitro using synthetic non-replicating virus; BSL3 for replicating virus in works.
• Influenza A, B (Orthomyxoviridae family) – POC in works.
• HSC-derived CBR-programmed microglia for glioblastoma multiforme (GBM).
BME
• Ebola and Marburg (Filoviridae family) – POC in vitro using synthetic non-replicating virus.
• Venezuelan and Western Equine Encephalitis (Alpha viruses) – POC in works (designed).
• Nipah and Hendra (Paramyxoviridae family) – POC in works (designed).
• Lassa (Arenaviridae family) – POC in works (designed).
• Influenza A, B (Orthomyxoviridae family) – POC in works (designed).
• SARS-CoV-2 (Coronaviridae family) – POC in vitro using synthetic non-replicating virus.
Slide 12:
CBR/BME Administration for Viral Infections
{Several charts that cannot be made out}
Advantages:
• Self-replication mRNA.
- longer lasting expression
- higher density of CBR
- higher production of BME
• Targeted polymer biodegradable nanoparticles
- cell specificity
- reduced immunogenicity
- improved handling and deployment
Slide 13:
CBR Administration for Brain Tumors
Depicts two diagrams:
1. In vivo proof of concept
Model: Systemic migration and engraftment of human WBC in immunodeficient mice
2. Human Administration concept
Microglia specific expression of CBR can treat glioblastoma multiforme (GBM) patients.
Advantages:
• Edited autologous HSC derived microglia
- Cross Blood Brain Barrier (BBB)
- No rejection
- Long anti-cancer surveillance
- Unlimited source of CBR programmed cells
Slide 11:
CBR Proof of Concept
Proof of Concept
• Demonstrated in vitro that immune cells programmed aith CBR against SARS-CoV-2 selectively consume live synthetic virus that carries (i.e. is pseudo-typed with) the Spike envelope protein of SARS-CoV-2 virus on its surface.
• Demonstrated that the function of CBR was not affected by known mutations of the Spike protein.
• Currently conducting in vitro and in vivo tests in BSL-3 facility to demonstrate that CBR can be used against infectious replicating SARS-Cov-2 virus.
• Identified and optimized a target protein (bait) that is being incorporated into a multipurpose CBR-based and BME-based therapeutic capable of treating multiple viruses that belong to different viral families instead of having to make a separate CBR or BME construct for every virus. Among the targeted viruses are Dengue and Zika (Faviviridae family), Ebola and Marburg (Filoviridae family) and Chikungunya (Togaviridae family).
Extensive Scope for Expanding Applications
• Expand potential use of CBR and BME to treat bacterial infections and cancer.
• Several modifications of the original design of CBRs enable the generation of cell-independent constructs which can be used as off-the-shelf drugs for the treatment of both viral infections and cancers – BME and AME.
Slide 9:
CBR- Chimeric Bait Receptor and BME – Bait Macrophage Engager Design Concepts I
What is CBR?
• CBRs program the immune cells that are responsible for innate immunity to precisely target and eliminate a range of pathogenic viruses and cells.
• CBRs contain a portion of the protein to which a pathogenic virus or cell binds, acting as bait for the virus or cell and allowing immune cells to destroy them.
• CBRs are used in the context of cell therapy treatment.
What is BME?
• BMEs redirect the immune cells that are responsible for innate immunity to precisely target and eliminate a range of pathogenic viruses and cells.
• BMEs contain a portion of the protein to which a pathogenic virus or cell binds, acting as bait for the virus or cell and allowing immune cells to destroy them. BMEs also contain a ligand for an immune cell receptor.
• BMEs enable the generation of cell-independent constructs that will be used as off-the-shelf drugs for the treatment of viral infections as well as certain types of cancer.
Slide 10:
{A 'cartoon' illustrating CBR mechanism and BME mechanism for eliminating SARS-CoV-2.}
Slide 7:
Unmet Need – Brain Cancers
Threats
Brain cancers including gliomas.
Solution
We have developed a fundamentally new cell therapy – Chimeric Bait Receptor – that will be used in combination with programed haematopoietic stem cells (HSC) to cross blood brain barrier (BBB) to eliminate brain tumors.
Goals
Develop reliable treatment of malignant brain tumors such as glioblastoma multiforme (GBM).
Slide 8:
Why Do We Need New Solutions
Shortcomings of Existing Methods of Combating Viral Infections
• Vaccines – sensitive to emerging mutations of the virus; designed to fight only one viral species.
• Anti-Viral Drugs – sensitive to emerging mutations of the virus; difficult and slow to develop; designed to fight only one viral species.
• Antibodies – sensitive to emerging mutations of the virus; designed to fight only one viral species.
Advantages of CBR/BME
• CBRs/BMEs are insensitive to emerging mutations of the virus
• CBRs/BMEs are assembled from parts of naturally occurring cellular receptors/ligands that are responsible for the function of immune cells and endow the host’s immune system with the ability to destroy invading pathogens.
• CBRs/BMEs are modular synthetic receptors/biologics that can be rapidly reconfigured to attack a multitude of viruses often belonging to different viral families. They can also be used to fight bacterial infections and certain types of cancer.
• CBRs/BMEs can be configured to have long shelf life and easy deployment/administration at ambient temperatures.
Slide 4:
Bait Biotechnology is developing:
1. Product type: Antivirals. Brain cancers treatments.
2. Mechanism of action: BAIT based programing or redirection of macrophage using novel synthetic proteins.
3. Significant Advantages:
a. Single therapeutic targeting multiple viral infections.
b. Long shelf life at ambient temperature.
c. Easy deployment/administration at ambient temperature.
d. Cross Blood Brain Barrier to target brain tumors.
Slide 5:
Unmet Need – Viral Infections
Threats
- Global pandemics
- Biological warfare
Solution
We have developed a fundamentally new cell therapy – Chimeric Bait Receptor – and its derivatives, including Bait Macrophage Engagers (BME) - that will be used to prevent and/or combat infection by any known or emerging virus.
Goals
- Prevent future global pandemics
- Render virus-based bio-threats ineffective
- Provide American warfighters with an overwhelming advantage over adversaries that use biological warfare
Slide 6:
Antivirals and Vaccines
{Several bar charts showing Global market size, and expected US$ CAGR in treatment sales over what appears to be next ten years, for the following.}
Global Market Size for Antivirals
Global Market Size for Dengue treatments
Global Market Size for Influenza treatments
Global Market Size for Covid-19 treatments
Global Market Size for Ebola treatments
Global Market Size for Marburg treatments
In what follows I will post the information given on the slides as far as it can be ascertained:
Slide 1:
BAIT Biotechnology
Outsmart – Prevent - Cure
Immune Cell Programming
Chimeric Bait Receptor (CBR) Platform
Bait Macrophage Engager (BME) Platform
September 2023
Slide 2:
Company Overview
• Hemogenyx Pharmaceuticals developed a novel platform for the development of radically new treatments of existing and emerging viral infections and certain types of cancer. The platform is being spun out as a subsidiary Bait Biotechnology (PCT/US2023/063514).
• Hemogenyx Pharmaceuticals and Bait Biotechnology are in West Harlem of Manhattan, New York City.
Bait Biotechnology enjoys:
1. Access to the R&D infrastructure of Hemogenyx Pharmaceuticals.
2. Access to the manufacturing infrastructure of Hemogenyx Pharmaceuticals
3. Access to a network of Advisors, Board of Directors, business and fundraising experience as well as talent of its parent company.
Slide 3:
Experienced Team
Vladislav Sandler, CEO
Andrew Wright, Financial Controller
Alexis Sandler, Non-Executive Director
Sir Marc Feldman, Chairman (Lasker Award)
Peter Redmond, Non-Executive Director
Koen van Besien, Clinical Adviser
Michael Sheppard, Scientific Adviser (Lasker Award)
Alan Walts (Board Adviser)
In September 2023 Vlad took part in the RESI Boston Innovators Pitch Challenge
(RESI - Redefining Early Stage Investments)
A video of the pitch was circulated later online - otherwise, HEMO's participation in this was not communicated to investors.
Primarily the purpose seems to have been the introduction of the company's CBR platform and its proposed future development, through a subsidiary BAIT Biotechnology, to an investor audience.
At the very end of the presentation a representative of Prevail Therapeutics interjects to advise that they are 'a committed investor' in Hemogenyx and for anyone interested in joining them to come and talk them afterwards. Thinking about it now - Prevail may have arranged for Vlad to participate in this, as Prevail may be a regular attendee at such events.
Here is the link to the youtube video again:
https://www.youtube.com/watch?v=X8tYUMq1Oo0
PT, vague recollection is that in one of the Q&A's, possibly at the AGM, another investor asked about HEMO-SAFE-CAR-T and the response was along the lines that, although they had developed a safety switch (to counter potential cytokine storm), they have not used it in HEMO-CAR-T as third generation CAR-T (and I think this may be in general now) does not show any significant signs of CRS, and are considered safe enough, based on pre-clinical studies - or words to that effect. I presume that this decision would have come as a result of the development and tests under the collaboration with UPenn.
JHFH - my thoughts too - today's RNS makes CDX eminently more partnerable, with someone to help take it into IND and clinical trial.
HEMO CAR-T - FDA decision pending.
Meanwhile CBR is being spun out into BAIT Biotechnology (a subsidiary) at some point 'coming soon' with new investment - to take that forward against viruses and some brain cancers. Per the September slides (Vlad used at the RESI Boston conference) - CBRs/BMEs for several families of viruses are 'in works', 'designed' - the technology is ready for translational science to develop and test products.
Here's the link to the RESI Boston Innovator's Pitch as it's been long since buried:
https://www.youtube.com/watch?v=X8tYUMq1Oo0
I may post some more detail from the slides over the weekend, when the quantity of posts has died down.
HH, my thoughts too, I'd hope the next raise is circa £20m and the next stage of each product CAR-T, CDX and CBR is funded.
Hopefully Dr Alan Walts has been doing his bit to prepare/engage PIPE funding round investors over the last two years as well as Prevail. And as Prevail were taking a 'still pre-clinical' placing risk there is reason to consider that their 6p minimum funding level injection was at a discount to the PIPE price.
Then a strategy of buying at each past dilution to maintain 20% more shares than the percentage ownership you ultimately want to hold (after dilution) may be well rewarded.
Apologies if already posted. Action Stations - CBR Team?
https://www.linkedin.com/posts/vladislavsandler_no-virus-will-escape-activity-7154309222757728256-nixV?
Michael Haugbro, Ronen ben Jehuda and Vladislav Sandler
For those that were considering company valuations (tweeted by Vlad a while back):
https://twitter.com/vmsandler/status/1630290333148884992/photo/1
Many years - I hope. This is just the start of the HEMO Fountain.
Great team of young scientists, new facilities, top life sciences location, latest equipment, proven advisors and mentors - and, we are told, potential for solutions to a range of illnesses through CAR-T, CDX and CBR, and I expect that there is much more that we do not know about.
PIPE Funding Round
When the Prevail Partners investment was first announced on a Prevail news item they stated that they had invested as part of Hemogenyx's PIPE funding round (I remember having to look up what PIPE stood for).
Here's some literature on what that might mean. After reading the initial summary pages scroll down to the UK section.
https://www.bakermckenzie.com/-/media/files/insight/publications/2020/06/global-private-investment-in-public-equity-guide-050620.pdf
I think this is already lined up and led by Prevail, since, as Vlad has confirmed in the penultimate RNS, there is a disconnect between the market price and the value. What will the price be and how much will be raised?